Point of care testing in Croatia: a survey of the Working group for point of care testing of the Croatian society of medical biochemistry and laboratory medicine

Graphical abstract


Introduction
Point-of-care testing (POCT) is defined as testing performed in the proximity of patient care, out-side the central laboratory environment (1-5).This allows for more expeditious clinical decisions and speeds up patient management.The unprecedented advances in technology and miniaturization, along with the shorter turnaround time (TAT) of POCT results have led to an increased demand for POCT in all healthcare settings which is witnessed by the exponential growth of the POCT market worldwide (6)(7)(8).
Over time, the number and type of analyses performed near the patient's bedside have increased due to its many advantages.Besides the shortened TAT, decreased iatrogenic blood loss, rapid response to critical results, and decreased therapeutic TAT are some of the main reasons why the implementation of POCT devices should be considered.However, the benefits of implementing POCT must be carefully weighed against its limitations.
Point-of-care testing is usually performed by nonlaboratory staff, emphasizing the need to organize, evaluate and monitor training and competence for all personnel performing POCT (2,5).Education should be an ongoing process and must include theoretical and practical information (5).Since POCT is performed outside the central laboratory, it is very important to establish a management system (including quality control, consumption of reagents, critical results, duplicate samples, competence evaluation, documentation control etc.) supervised by a body including laboratory professionals (4,5).To ensure good quality, all personnel should be actively involved in POCT implementation (5).
Preanalytical errors are the most common in POCT and include incorrect timing of sample collection, errors in blood collection, errors in patient identification, errors in sample collection, underfilled tubes, inadequate mixing of samples and hemolyzed samples that can cause false results (4,9,10).Failure to detect them can cause wrong medical decisions and negatively affect patient safety.Today there is a growing awareness that the majority of problems that arise with POCT are due to incorrect implementation of POCT devices.These problems are due to incorrect sampling techniques, poor operator experience and training, inappropriate interpretation of results and the absence of appropriate quality control procedures (4).All these problems can lead to unreliable results that may have serious implications for patients.
There are several international guidance documents for POCT that focus on quality management, selection of point of care testing devices based on patient care and clinical needs, and guidance for users of in vitro diagnostic devices outside the central laboratory to ensure reliable results comparable to those from central laboratories (5,11,12).Similarly, in recognition of the growing interest in POCT in Croatia, the Croatian chamber of medical biochemists (CCMB) recognizes POCT as an integral part of laboratory diagnostics.Therefore, the Croatian ministry of health issued two national regulations concerning POCT diagnostics in 2005 and 2019.These regulations were issued in collaboration with the CCMB and the Croatian medical chamber (CMC).According to both documents, POCT must be performed under the supervision of a central laboratory.
In 2015 the Croatian society of medical biochemistry and laboratory medicine (CSMBLM) established a Working group for point of care testing (WG POCT) whose main aim is to propose national standards for POCT implementation, in and outside the hospital setting.Our hypothesis is that there is little or no control for POCT at the national level despite existing regulations.Therefore, we conducted a survey among non-laboratory and laboratory staff to review current attitudes and practices regarding POCT in Croatia.The aim was to identify the weakest points and find solutions for improvement.

Study design
The study was conducted using two anonymous surveys written by members of the CSMBLM's WG POCT and targeted to laboratory professionals and clinical staff in general.It

Statistical analysis
The results are presented as numbers and percentages (if N ≥ 100) or numbers and proportions (if N < 100).The SurveyMonkey online survey platform was used for data collection and calculation.

Results
A total of 112 non-laboratory healthcare professionals and 50 laboratories participated in the survey, which corresponds to a response rate of 0.25% for non-laboratory healthcare professionals and 27% for MBLs (according to the Croatian health statistics yearbook 2015 there were a total of 44,142 healthcare workers: nurses and physicians).
The general characteristics of the participants are presented in Table 1 and attitudes and routine practices related to POCT for non-laboratory healthcare professionals are presented in Table 2.
In addition to the basic POCT questions, the survey for non-laboratory and laboratory professionals included questions about the use of POCT devices in routine work, so not all participants answered all questions.2. The majority of non-laboratory healthcare professionals using POCT declared a faster patient management process, shorter length of stay, and reduced number of samples sent to the central laboratory for testing.However, 0.79 (60/76) of respondents stated that they send an additional sample to the laboratory for retesting in case of an uncertain POCT result: most often in case of discrepancies between POCT results and clinical presentation, critical or unreliable POCT results.The majority of respondents (76/84) declared that POCT results are always stored in the patient's medical record.

Discussion
The development of a range of POCT devices that provide clinicians with laboratory test results more quickly could provide an opportunity to improve the quality of patient care.Since POCT involves tests conducted outside of a laboratory setting, it is crucial to focus on the implementation process and ensure consistently high quality at every step.
In this study, we aimed to investigate attitudes and routine procedures in POCT testing among nonlaboratory and laboratory healthcare professionals in Croatia.Our results show that laboratory professionals are aware of the national POCT regulations but in general, not all of them are actively involved in POCT implementation and supervision.Another significant result is poor communication between non-laboratory and laboratory healthcare professionals in the POCT field.These results confirm our hypothesis on poor POCT control nationwide and call for immediate action in terms of applicable guidance documents.
The majority of participants, both laboratory and non-laboratory professionals, consider POCT as a medical tool that enables better patient care, primarily because of the rapid availability of test results.Similar results were obtained in a study among general practitioners in Germany, where the vast majority of participating German general practitioners (93%) rated POCT as a useful diagnostic tool in their practice (13).In our study the majority of non-laboratory healthcare professionals (0.66) stated that no education on the POCT device used was provided, while a great proportion of non-laboratory users declared that training was performed exclusively by POCT suppliers/ manufacturers.If we consider the statement that POCT allows clinicians to make clinical decisions without sending patients to the emergency department and that they do not always repeat the analysis in the central laboratory, communication between non-laboratory and laboratory personnel is imperative to ensure patient safety.
Proper training of non-laboratory personnel in the use of POCT equipment can change the way patients are treated and have tremendous benefits for health care overall.Training must include the basic operating steps of a POCT instrument, information about sample preparation and common analytical interferences, recognizing unreliable results, comparing POCT results with results from the central laboratory-whether the methods are comparable, whether there are sample-specific differences between POCT and the central laboratory etc. (5).When conducting training, one should always keep in mind the lack of laboratory knowledge among clinical staff.This could be quite a challenge, as the use of POCT devices requires prior knowledge of preanalytical and analytical issues.This knowledge can better identify errors and prevent incorrect clinical decisions.
Hospitals have their own laboratories, but the situation is different in primary care because not every primary care physician has a laboratory nearby.The great benefit of POCT could be seen in primary health care as a first-line treatment for the patient.Our study included only a small number of primary care participants, but their comments about how POCT helped them avoid sending a patient to the emergency department are significant.Implementing POCT in primary care could provide economic benefits by reducing the burden on the emergency department.However, this should be done using standard practices, guidelines, and regulations.All parties involved in POCT should cooperate, i.e. suppliers/manufacturers on the one end and a POCT team made up of laboratory professionals and clinical staff on the other.Implementation is crucial for the safe use of POCT.Every participant's responsibilities should be clearly outlined in this first step.Using POCT as an auxiliary medical tool without proper education is not only unsafe for the patient but also a financial burden on the healthcare system.Since this diagnostic is growing rapidly, more enthusiasts are needed to initiate the safe and cost-effective implementation of POCT diagnostics.
Our study shows that the laboratory staff is aware of what is mandatory for POCT but there is still a lack of communication with clinical staff.Laboratory professionals should explain how POCT should be used using a scientific and professional background.Clinical staff wants fast diagnostics that allow fast treatment introduction, reduction in hospital stays, and satisfied patients.It is therefore mandatory that these two professions work closely together to choose the right POCT device for the right patient.In addition, they must resolve unexpected results.This is to prevent more serious consequences for the patient due to an incorrect report.Point of care testing has become the standard in critical emergencies due to the immediate availability of critical results and rapid therapeutic turnaround time.The goal of POCT is to enable rapid response and improve patient outcomes, not to increase the incidence of medical errors.In the study from Kost, experts recommended validating trained and certified operators before using hospital-based instruments for POCT (14).
It should also be emphasized that our study has some limitations.Firstly, the low response rate of this nationwide survey hampers the generalization of the results.However, it must be noted that our results provide a fair understanding of Croatia's POCT routine practice.Furthermore, our participants self-reported and could not be independently verified.
In conclusion, this study shows that non-laboratory and laboratory staff consider POCT as a tool for better patient care, and they know the need for training and performing quality control.Our study will help the WG for POCT create proper national guidelines for implementing and managing POCT.

Table 2
and 3 also show the number of participants for each question.Statement Answer, N (%) or N (

Table 1 .
General characteristics of participants 3. Implementation of new POCT devices and their organization should be the responsibility of: (N = 112) 4. In your routine practice, do you use POCT devices or results obtained from POCT devices?(N = 112)

Table 3 .
Answers provided by laboratory healthcare professionals